Recalls / Class II
Class IID-0269-2015
Product
HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
- Affected lot / code info
- 141015FF, 11/15/14; 141024KK, 11/24/14; 141031CC, 12/1/14
Why it was recalled
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recalling firm
- Firm
- Perry Drug Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 12200 W 106th St Ste 140, N/A, Overland Park, Kansas 66215-2305
Distribution
- Quantity
- 3 vials
- Distribution pattern
- Kansas and Missouri
Timeline
- Recall initiated
- 2014-11-07
- FDA classified
- 2014-11-24
- Posted by FDA
- 2014-12-03
- Terminated
- 2015-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0269-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.